Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial

Not Applicable

Active, not recruiting

Conditions: Root Canal Obturation

Registration Number: NCT04757753

Lead Sponsor: Septodont

Brief Summary: The study design is a multicentric randomized controlled non-inferiority trial. 160 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (80 in each group). The aim of the study is to assess the efficacy rate and the safety 2 years after root canal obturation undertaken using a ready-to-use calcium silicate sealer (PA1704) compared to the control calcium silicate sealer BioRoot™ RCS.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRoot™ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months in both groups. The performance and safety of the sealer PA1704 will also be evaluated at 3.5 and 5 years after surgery. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 160

Inclusion Criteria

Adult male or female (age ≥ 18 years)
Patient requiring a primary or a secondary root canal obturation on a single or multi-rooted tooth,
Patient geographically stable who can be followed by the same investigator site for 2 years,
Informed consent signed,
Patient with social protection

Exclusion Criteria

Patient with one or more documented contraindication to endodontic treatment,
Contraindication to the use of calcium silicate root canal sealer, such as an immature tooth or a known hypersensitivity to one component of the sealer formula,
Endodontic treatment on tooth with calcified root canal assessed radiographically,
Endodontic treatment on tooth with suspected perforation,
Patient with an uncontrolled systemic disease such as diabetes or thyroid disorders, or with an immunocompromised condition or who has undergone radiation therapy to the jaw.
Patient suffering from uncontrolled active periodontitis, not supported
Participation to another interventional clinical study at the same time,
Vulnerable subjects referred to in articles L.1121-5 to 8 and L.1122-1-2 of the Public Health Code and article 66 of Regulation (EU) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy Rate of Root Canal Obturation	24 months post-treatment	Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation.

Secondary Outcome Measures

Name	Time	Method
Efficacy Rate of Root Canal Obturation	6 months post-treatment	Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation. The efficacy rates was compared between the 2 groups at 6-months post-treatment.
Radiological Evaluation of the Canal Obturation	24-months post-treatment	Radiological evaluation of the level of apical obturation and density. The level of apical obturation and density is measured by the Investigators on the retroalveolar radios, like the "Sufficient radio-opacity" of the ready-to-use root canal sealer under investigation, "Presence of at least one bubble (void) in the filling material", and "If extruded material at T0, extruded material still presents in the periapical space".
Postoperative Pain	Before endodontic treatment; before session#2 initiation; T0 (after canal obturation); 12; 24; 48; & 72h; 7 days after endodontic treatment. Evaluation on same day for 1-session treatment; up to 18 days before if 2 sessions needed. **On same day.	The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm, from no pain to max pain) at different times after endodontic treatment (at the end of the root canal obturation, 12h postoperative, 24h, Day 2, Day 3, Day 7). The maximum pain felt will be compared between the 2 groups. To note: the endodontic treatment was performed in 2 sessions for some patients. For those patients, there is an additional pain evaluation done before the session 2.
Use of Oral Pain Treatment	From Day 0 to Day 7	Patients reported the consumption of analgesic treatment in a diary. The percentage of patients who took oral pain medication will be compared between the 2 groups.

Trial Locations

Locations (4): Cabinet dentaire
🇫🇷
Saint-Grégoire, France
Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie
🇧🇪
Bruxelles, Belgium
Centre de santé dentaire Flandre
🇫🇷
Paris, France
Cabinet dentaire Jeanne d'Arc
🇫🇷
Rouen, France